Extensive project management expertise and logistical control know-how are obviously required when working on a combination product, from the concept stage to its eventual launch. Cross-functional teams from both the biopharmaceutical company and the device supplier must work together for several years to coordinate efforts in a collaborative manner, overcome related challenges and ensure that the right steps are taken. Taking into account the number of biologics coming into the market and the entry of biosimilars, we see an increasing number of biopharmaceutical companies in need of such services provided by a broad number of suppliers and specialists across various geographic areas.

Over the years, a few early-mover biopharmaceutical companies gained valuable experience by producing their own devices, working with the suppliers of devices and by establishing a good rapport with companies providing related services. These early-movers have experienced first-hand the extensive number of pieces within the combination product puzzle that needs to be put together to move forward with a device such as an auto-injector.

Some of the choices that need to be made by the biopharmaceutical company include selecting a suitable primary container, filling supplier, regulatory consultants, human factors engineering (HFE) experts, final assembly integrators, and so on - all vital to the successful launch of your device. And the benefits of bringing an innovative device to the market clearly make the investments of time, finances and resources worthwhile for the biopharmaceutical companies.

Development

Taking a product, such as an auto-injector, from early design towards mass production is a complex process. Development involves several stages such as planning, design, engineering and process validation. As a project moves forward, having both design and development teams in the same company is ideal, but not always possible. For example, mechanical or technical design of the device may come from the device company, but the biopharmaceutical partner may choose to utilize an external industrial design company for appearance of the device. Involving another party may certainly add a new flavor to the uniqueness of the product, but doing so may also slow down the overall development of the device by simply adding to the growing number of voices involved in your project. At the end of the day, there are pros and cons to both approaches.